Rebellion, Phantom Multi-Bite Kerrison Rongeur

K230256 · Morpheus AG · HAE · Mar 3, 2023 · Neurology

Device Facts

• Record ID: K230256
• Device Name: Rebellion, Phantom Multi-Bite Kerrison Rongeur
• Applicant: Morpheus AG
• Product Code: HAE · Neurology
• Decision Date: Mar 3, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

Device Story

Rebellion is a manual bone punch (Kerrison Rongeur) used in orthopedics, neurosurgery, and spine surgery. Device features a long shaft (160, 200, or 250 mm) with a 90-degree up-biting tip (2-4 mm bite size). Operated manually by surgeons to cut and remove bone/tissue. Includes a posterior tube connection for integration with a suction system or Morpheus Bone and Tissue Trap to facilitate debris removal. Used in clinical settings (OR). Provides mechanical bone removal; suction capability assists in clearing surgical site. Benefits include efficient bone/tissue resection and improved visualization via integrated suction.

Clinical Evidence

No clinical performance testing was submitted. Substantial equivalence is supported by non-clinical performance testing, including shelf-life validation of the sterile barrier system.

Technological Characteristics

Manual rongeur; stainless steel (420, 304, 302) and polymers (PVC, ABS, PA6 GF60, TPE, Fluoropolymer). 160/200/250 mm lengths; 90° up-biting tip. Suction-enabled via posterior tube connection. Sterile, single-use. Shelf life: 5 years. Packaging: double-packed PET/PP composite film. ISO 11607-1 compliant.

Indications for Use

Indicated for cutting and removing bone, vertebral bodies, and tissue in patients undergoing orthopedic, neurosurgical, or spinal procedures involving the skull or spinal column.

Regulatory Classification

Identification

A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.

Predicate Devices

• Rebellion (K200768)
• Rebellion (K221818)

Submission Summary (Full Text)

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March 3, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Morpheus AG Dimitri Krutsch QM / RA Manager Bahnhofstraße 18 Spaichingen, Baden Würrtemberg 78549 Germany

Re: K230256

Trade/Device Name: Rebellion, Phantom Multi-Bite Kerrison Rongeur Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: January 30, 2023 Received: January 31, 2023

Dear Dimitri Krutsch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

Adam D. Digitally signed by Adam D. Pierce -S Pierce -> 0ate: 2023.03.03.03

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230256

Device Name

Rebellion, Phantom Multi-Bite Kerrison Rongeur

Indications for Use (Describe)

The Rebellion is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| DATE OF APPLICATION: | 01/30/2023 |
|----------------------|------------|
| 510(k) Number: | K230256 |

APPLICANT:

Morpheus AG Bahnhofstrasse 18 78549 Spaichingen Germany Tel: + 49 (0) 7461 70382-0 E-Mail: [e-mail]

UUNIAUI PEKSUN:

Dimitri Krutsch QM / RA Manager Tel.: [phone] E-Mail: [e-mail]

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#### Device Name 1

| Trade Name: | Rebellion;<br>Phantom Multi-Bite Kerrison Rongeur | | |
|-----------------------------|---------------------------------------------------|--|--|
| Common Name: | Kerrison Rongeur | | |
| Device Classification Name: | Manual rongeur | | |

#### Classification / Product Code 2

Rebellion can be classified according to following device name and product code:

| Device | Regulation<br>Description | Regulation<br>Medical Specialty | Product Code | Regulation<br>Number | Device<br>Classification |
|-----------|---------------------------|---------------------------------|--------------|----------------------|--------------------------|
| Rebellion | Manual rongeur | Neurology | HAE | 21 CFR<br>882.4840 | II |

#### 3 Predicate Device / Reference Device

| Subject Device | Predicate Device | Reference Device | 510(k) number | 510(k) Holder |
|----------------|------------------------------------------------------|------------------|--------------------|---------------|
| Rebellion | Rebellion;<br>Phantom Multi-Bite<br>Kerrison Rongeur | — | K200768<br>K221818 | Morpheus AG |

#### Device Description 4

The REBELLION is a Bone Punch and it is available in the length 250 mm, 200 mm and 160 mm with tree different tip sizes (2, 3 and 3 mm). At posterior tube the Rebellion can be connected to the Morpheus Bone and Tissue Trap or to a standard suction system via sterile tubing.

Image /page/4/Figure/10 description: The image shows a black and green tool with a long, thin black shaft. The handle of the tool is black with green accents and has a trigger-like design. The shaft extends from the handle and has a small, silver-colored tip. The text at the bottom of the image says "Figure 1: Rebellion".

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#### Indications For Use 5

The REBELLION is intended for cutting and removing bone, vertebral bodies and tissue in orthopedics, neurosurgery and spine surgery involving the skull or spinal column.

#### e Technological Characteristics

Morpheus Rebellion possesses similar technological characteristics as compared to the predicate device K200768 and K221818. Different characteristics do not raise different questions of safety and effectiveness, and scientific methods were applied to evaluate different characteristics' effects on safety and effectiveness.

| Description | Subject Device | Predicate Device<br>Morpheus AG<br>(Rebellion) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K230256 | K200768<br>K221818 |
| Product Code | HAE | HAE |
| Class | II | II |
| Regulation # | 882.4840 | 882.4840 |
| Classification Name | Manual, Rongeur | Manual, Rongeur |
| Indication for Use | Identical | The Rebellion is intended for cutting and<br>removing bone, vertebral bodies and tissue<br>in orthopedics, neurosurgery and spine<br>surgery involving the skull or spinal column. |
| Anatomical location | Skull and spine | Skull and spine |
| Sterility | Sterile | Sterile |
| Re-Use | No | No |
| Material | Stainless Steel: 420, 304 and 302<br>Polymer: PVC, ABS, PA6 GF60 (Grivory GV-<br>6H); TPE (TM5MED) and Fluoropolymer<br>(Altera MT1000A) | Stainless Steel: 420, 304 and 302<br>Polymer: PVC, ABS, PA6 GF60 (Grivory<br>GV-6H); TPE (TM5MED) and Fluoropolymer<br>(Altera MT1000A) |
| Patient Contacting | Stainless Steel: 420, 304<br>Polymer: Fluoropolymer (Altera MT1000A) | Stainless Steel: 420, 304<br>Polymer: Fluoropolymer (Altera MT1000A) |
| Design features | Manual Rongeur | Manual Rongeur |
| Bone Removal | Suctional function | Suctional function |
| Shaft-length | 160, 200 and 250 mm | 160, 200 and 250 mm |
| Jaw opening | 14 mm | 14 mm |
| Bite size | 2 - 4 mm | 2 - 4 mm |
| Cutting angulation | 90° up-biting | 90° up-biting |
| Packaging (sterile<br>barrier system) | double packed in a PET/PP composite film | double packed in a PET/PP composite film |
| Shelf life (packaging) | 5 years | 2 years |

### 6.1 Device Characteristics Table

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#### Performance Data 7

# 7.1 Clinical performance testing

Clinical performance testing was not submitted in this 510(k).

## 7.2 Non-Clinical performance testing

The subject device does not represent a new worst-case when compared to the previously cleared Morpheus REBELLION Rongeur (K200768 and K221818).

To verify the shelf life of the sterile barrier system (SBS), a shelf-life validation according to ISO 11607-1 was performed for 5 years.

#### Conclusion 8

In accordance with 21 CFR Part 807 and based on the information provided in this premarket notification, Morpheus AG concludes that the Rebellion Rongeur is as safe and as effective for their intended use as the predicate devices, the Rebellion Rongeur (K200768 and K221818).